Two weeks from today, the Drug Controller General of India gave permission to Biocon’s Drug Itolizumab for the treatment of COVID-19 patients. Bit yesterday with the release of National Treatment Protocol For COVID-19 patients by Union Health Ministry- Itolizumab is not included in the list of drugs provided for the treatment.
Itolizumab was dedicated to using for the patients with mild to severe symptoms of Coronavirus. But union health ministry in its justification for the rejection of the drug said “very less evidence in favor of this medicine.” Resulting in the dropping of Bicon’s share price.
Biocon was questioned for using only 30 patients for the testing of the drug. In its response Biocon cleared that this drug was previously approved for the treatment of Psoriasis and all the procedures followed in the use of this Drug for COVID-19 patients is as [er International norms.
The Statement Biocon read as “The National COVID Task Force needs to see more evidence and we will provide them large real-world data to enable the committee to reconsider its decision on inclusion of itolizumab in the protocol. Nearly 1,000 patients have used the drug across the country with good outcome data.”
It is further added in the statement that “Also, we have already announced that we have planned for a 200 patient pan India phase 4 trial to be conducted across 10-15 hospitals. The study protocol has been submitted to the DCGI and we will commence the trial soon.”